Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction

Last updated: September 8, 2022
Sponsor: Affiliated Hospital of Nantong University
Overall Status: Active - Recruiting

Phase

4

Condition

Perimenopause

Treatment

N/A

Clinical Study ID

NCT05021094
AHNantong-POI
  • Ages 18-39
  • Female

Study Summary

To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The women aged <40 years old.
  2. Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twiceinspection (two occasions >4 weeks apart). Rare menstruation or menopause for at least 4 months.
  3. Individuals meeting the above criteria who voluntarily consented to studyparticipation.

Exclusion

Exclusion Criteria:

  1. Pregnant and lactating patients;
  2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids,endometrial polyps, etc.), hysteromyoma > 4cm or hysterectomy;
  3. Patients with known or suspected breast cancer history and estrogen-dependentmalignant tumor;
  4. Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index > 30 kg/m2, smoking and family history of thrombosis);
  5. Patients with porphyria;
  6. Patients with serious primary diseases or mental illness such as cardiovascular,liver, kidney and hematopoietic system;
  7. Patients who are participating in other clinical trials or have participated in otherclinical trials in the past three months;
  8. Patients who suspect or have a history of alcohol and drug abuse;
  9. Patients who are known to be allergic to the test drugs or their components;
  10. The researchers determined that patients are not suitable for this trial.

Study Design

Total Participants: 120
Study Start date:
October 22, 2021
Estimated Completion Date:
December 31, 2023

Study Description

The study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.By comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, The principal investigator will write and publish the paper.

Connect with a study center

  • Hai'an People's Hospital

    Hai'an, Jiangsu 226600
    China

    Active - Recruiting

  • Hai'an Hospital of traditional Chinese Medicine

    Huai'an, Jiangsu 226600
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu
    China

    Active - Recruiting

  • Nantong First People's Hospital

    Nantong, Jiangsu 226001
    China

    Active - Recruiting

  • Nantong Hospital of Traditional Chinese Medicine

    Nantong, Jiangsu 226001
    China

    Active - Recruiting

  • Rugao Boai Hospital

    Ru'gao, Jiangsu 226500
    China

    Active - Recruiting

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